Diagnostic and Monitoring Significance of ctDNA Methylation Analysis by NGS in Benign and Malignant Pulmonary Nodules

  • End date
    Jun 24, 2023
  • participants needed
  • sponsor
    AnchorDx Medical Co., Ltd.
Updated on 21 February 2022
ct scan
chest ct
Accepts healthy volunteers


AnchorDx is using circulating tumor DNA (ctDNA) methylation analysis by next-generation sequencing (NGS) to develop a blood-based assay for differentiating benign and malignant pulmonary nodules early. The purpose of this study is to evaluate the diagnostic performance of this assay in patients with pulmonary nodules.


This is a prospective, multi-center, observational cohort study and seeks to enroll 10,560 participants with pulmonary nodules smaller than 3 cm in diameter from 21 hospitals in China. All participants will be followed up with chest CT or low-dose computed tomography (LDCT) scans for 2-3 years ( baseline, 3 months, 6 months, 12 months, 24 months and 36 months). Their blood samples, CT or LDCT scans data, and clinical data will be collected at each visit and Formalin-fixed paraffin-embedded (FFPE) tissues will be collected when participants who receive pneumonectomy or percutaneous lung biopsy.

Condition Pulmonary Nodules
Treatment ctDNA methylation analysis by NGS
Clinical Study IdentifierNCT03651986
SponsorAnchorDx Medical Co., Ltd.
Last Modified on21 February 2022


Yes No Not Sure

Inclusion Criteria

Years and older
pulmonary nodules diagnosed by chest CT or low-dose computed tomography (LDCT) scans
non-calcified pulmonary nodules with the diameter between 5mm to 30mm
including solid nodules, mixed ground-glass opacity nodules and pure ground-glass opacity lung modules
new cases of pulmonary nodules or diagnosed within 60 days prior to enrollment
agree to finish the Patient Pulmonary History Questionnaire
agree to be followed up for 2-3 years
agree to provide a written informed consent

Exclusion Criteria

pregnant or lactating women
received any pneumonectomy or percutaneous lung biopsy before enrollment
recipients of blood transfusions within 30 days prior to enrollment
patients with tumors identified within 2 years prior to enrollment except non-melanoma skin cancer
fail to understand or provide a written informed consent
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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